Aldeyra Therapeutics, Inc. announced completion of enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (intravitreal methotrexate 0.8%) in patients with proliferative vitreoretinopathy (PVR), a rare, sight-threatening ocular disease with no approved therapy. The GUARD Trial is a two-part, multi-center, randomized, parallel-group, adaptive Phase 3 clinical trial evaluating the efficacy of intravitreal injections of ADX-2191 versus standard of care (routine monitoring) for the prevention of PVR following retinal detachment repair. The primary endpoint is recurrent retinal detachment rates over a 24-week post-operative period.

Part 1 of the GUARD Trial, which enrolled 110 patients, is being conducted in the United States. Top-line results from Part 1 are expected in the second half of 2022. ADX-2191, a vitreous-compatible formulation of methotrexate, has been granted fast track and orphan drug designation by the U.S. Food and Drug Administration for the prevention of PVR.

Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, potentially accelerating patient access to new therapies. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials; exemption from user fees; and market exclusivity after approval, if received.